Category Archives: regulation

The Australian Pesticides and Veterinary Medicines Authority (APVMA) has release a final report with recommendations regarding nanotechnology regulation according to a July 13, 2015 news item on Nanowerk (Note: A link has been removed),

Publication of the report Nanotechnologies for pesticides and veterinary medicines: regulatory considerations—final report (July 2015) marks the culmination of four years of Australian Pesticides and Veterinary Medicines Authority (APVMA)-led research, consultation and collaboration.

The report considers the benefits and challenges of regulating nanotechnology for use in agriculture and animal husbandry, as advances in nanoscale science, engineering and technology pave the way for developing novel applications, devices and systems.

The report aims to inform and stimulate discussion about emerging nanotechnology and highlights the key regulatory considerations for agvet chemical nanomaterials based on the current state of knowledge.

It systematically explores the opportunities and risks of these substances in Australian agriculture and animal husbandry and reviews the published work relevant to the registration of nanoscale agvet chemicals.

A July 6, 2015 APVMA press release, which originated the news item, provides a brief history of the deliberations which led to the report and a brief description of the actions which will follow its publication,

In October 2014, the APVMA hosted a symposium on nanotechnology regulation, seeking national and international input from industry, scientists, regulators and the broader community on developing a regulatory framework for nanotechnologies in Australian agriculture and animal husbandry. Discussion was based on the APVMA draft report Regulatory considerations for nanopesticides and veterinary medicines (October 2014), the first of its kind to be made available for public discussion. Input subsequently received was considered in finalising the report.

Next steps

The APVMA will now use the report to finalise the regulatory approach for nanotechnology products, including:

building capability and expertise so new products can be evaluated effectively
analysing the data requirements
enhancing the existing regulatory framework if required as knowledge evolves
continuing to engage with the international scientific community so that the latest

One of the groups responding the US Environmental Protection Agency’s (EPA) request for comments (the deadline for comments was July 6, 2015 as per my April 8, 2015 posting about the consultation) on its proposed rule on reporting nanomaterials has publicized its comment/critique in a July 3, 2015 article by Caitlin Nordahl for EP Newswire,

Points well taken. Still, there is a ‘which came first, the chicken or the egg?’ situation with nanomaterials. There have been a few recent announcements about new protocols and characterization efforts which suggest that these are still very early days and there is much to be done. Meanwhile, the regulatory agencies are being pressured to do more where nanomaterials are concerned. The agencies are grappling with the problem of making a decision which could have a major impact, positive or negative, when there is little data. Hopefully, comments from Atlas and others (pro and con) will help policymakers to arrive at the best possible regulatory outcome.

For anyone interested in more detail about this consultation and some of the nanomaterial reporting history with regard to the EPA, Joshua Bloom had some interesting comments as per my excerpts in an April 22, 2015 posting.

A member of the legal firm, Barg Coffin Lewis & Trapp LLP, Joshua A. Bloom offers a description of the US Environmental Protection Agency’s (EPA) call for comments on its proposed rule on reporting nanomaterials in an April 16, 2015 posting on Nanotechnology Now,

For the first time, and after multi-year negotiations with, and review by, the Office of Management and Budget, the U.S. Environmental Protection Agency is proposing to use its authority under the federal Toxic Substances Control Act (TSCA) to require companies to provide information on existing nanoscale materials, in addition to reporting for new discrete nanoscale materials before they are manufactured or processed. …

According to EPA, the proposed information-gathering rule is required because more information is needed to understand potential environmental and health effects that may result from use of nanoscale materials. The Agency attempted to obtain similar information in 2008 and 2009 through its voluntary Nanoscale Materials Stewardship Program to “complement and support its regulatory activities on chemical substances manufactured at the nanoscale.” Notwithstanding that effort, EPA estimates that it received information on only about ten percent of nanoscale substances that were manufactured during that time period. …

I had heard about the voluntary program but never come across any data regarding its success or lack thereof. So, thank you Mr. Bloom.

He also provides information about the proposed exclusions,

Excluded from reporting requirements would be certain biological materials (e.g., DNA, RNA, and proteins). In addition, EPA is seeking comment on excluding other biological materials, such as microorganisms and viral-based products, lipids, carbohydrates, enzymes, and peptides. Also excluded would be chemical substances that dissociate completely from water to form ions that are less than one nanometer. EPA further proposes excluding nanoclays, zinc oxide, and chemical substances manufactured on a nanoscale as part of a film on a surface.

Here’s what the EPA does want to know,

The type of information that EPA would require to be submitted under the proposed rule would be similar to that requested under the Nanoscale Materials Stewardship Program—specific chemical identity, material characterization, physical chemical properties, production volume, use, methods of manufacturing, exposure and release information, and existing data concerning environmental and health effects. Such information would need to be submitted “to the extent it is known to or reasonably ascertainable by” the manufacturer or processor.

Also noteworthy is that EPA is seeking comment on consideration of potential future rulemaking regarding periodic reporting. …

For someone who’s interested in the ins and outs of this reporting requirement and attempts to reform the TSCA in Congress, Bloom’s post is a rewarding read. I last wrote about the EPA’s call for comments on its proposed rule on reporting nanomaterials in an April 8, 2015 post.

The U.S. Environmental Protection Agency (EPA) is proposing one-time reporting and recordkeeping requirements on nanoscale chemical substances in the marketplace. “Nanotechnology holds great promise for improving products, from TVs and vehicles to batteries and solar panels,” said Jim Jones, EPA’s Assistant Administrator for Chemical Safety and Pollution Prevention. “We want to continue to facilitate the trend toward this important technology. Today’s action will ensure that EPA also has information on nano-sized versions of chemicals that are already in the marketplace.”EPA currently reviews new chemical substances manufactured or processed as nanomaterials prior to introduction into the marketplace to ensure that they are safe. For the first time, the agency is proposing to use TSCA to collect existing exposure and health and safety information on chemicals currently in the marketplace when manufactured or processed as nanoscale materials. The proposal will require one-time reporting from companies that manufacture or process chemical substances as nanoscale materials. The companies will notify EPA of:

Nanoscale materials have special properties related to their small size such as greater strength and lighter weight, however, they may take on different properties than their conventionally-sized counterpart. The proposal is not intended to conclude that nanoscale materials will cause harm to human health or the environment; Rather, EPA would use the information gathered to determine if any further action under the Toxic Substances Control Act (TSCA), including additional information collection, is needed.

The proposed reporting requirements are being issued under the authority of section 8(a) under TSCA. The agency is requesting public comment on the proposed reporting and recordkeeping requirements 90 days from publication in the Federal Register. EPA also anticipates holding a public meeting during the comment period. The time and place of the meeting will be announced on EPA’s web page at: http://www.epa.gov/oppt/nano/Additional information and a fact sheet on the specifics of the proposed rule and what constitutes a nanoscale chemical material can be found at: http://www.epa.gov/oppt/nano/

On February 4, 2011, Prime Minister Stephen Harper and U.S. President Barack Obama announced the creation of the Canada-U.S. Regulatory Cooperation Council to better align the two countries’ regulatory approaches in various areas, including nanotechnology. As part of this initiative, a Nanotechnology Work Plan (PDF)(3 pp, 77K) was developed to increase regulatory transparency and coordination between both countries with respect to nanomaterials.

An important outcome of the initiative was the development of consistent policy principles on the regulatory oversight of nanomaterials, which have now been endorsed by Canada:

Regulatory Cooperation Council (RCC) Nanotechnology Policy Principles for Decision-Making Concerning Regulation and Oversight of Nanotechnology and Nanomaterials (PDF) (3 pp, 38K) [Unfortunately the link no longer to the document]

The final reports from this initiative address the issues listed below and include recommendations on ways Canada and the United States can align their work on nanomaterials that are classified as new substances, regulated in Canada and the United States under the Canadian Environmental Protection Act, 1999 (CEPA, 1999) and TSCA, respectively.

International Organization for Standardization (ISO)

The ISO has established a technical committee to develop international standards for nanotechnology. This technical committee, ISO/TC 229, is working to develop standards for terminology and nomenclature, metrology and instrumentation, including:

One final note, Canada held a similar exercise (a Canadian nanomaterial reporting plan/scheme/inventory that was announced in Jan. 2009) for which I was not able to find much information. From my April 12, 2010 post,

I was trying to reference the song, Amazing Grace, in my headline but I’m beginning to think I should be talking about invisibility cloaks. Still, glory halleluiah! I do believe I have found some information about the Canadian nanomaterial reporting plan/scheme/inventory that was announced in Jan. 2009 and which I’ve discussed elsewhere in this blog (most recently here).

What follows is all the information I was ever able to find about this Canadian initiative and all of it from an OECD document. I did try to follow up with Health Canada and have that response in my April 26, 2010 post.

A March 18, 2015 news item on Nanowerk announces a third NANoReg newsletter marking the halfway point in the project’s term (Note: Links have been removed),

NANoREG is the first FP7 project to deliver the answers needed by regulators and legislators on EHS [Environment, Health & Safety] by linking them to a scientific evaluation of data and test methods.

…

Time wise, the NANoREG project is now halfway. After setting the basic conditions for its R&D work, the project now focuses on the generation of reliable and comparable experimental data on the EHS aspects of the selected NANoREG nanomaterials. These data will form the basis for the main “end products” of the NANoREG project: the Regulatory Framework and the NANoREG Toolbox. Highlights of this experimental work and results will be shared with you in this 3rd NANoREG Newsletter (pdf).

The Regulatory Framework and the NANoREG Toolbox just mentioned will be developed in close cooperation with organisations involved in standardisation and in the regulatory aspects of nanomaterials like ECHA [European Chemicals Agency], OECD [Organization for Economic Cooperation and Development], CEN [European Committee for Standardization] and ISO [International Standards Organization]. The results of other EU FP7 [Framework Programme 7] and H2020 [Horizon 2020] [research funding] projects will also be taken into account when developing these products. One of these projects is the H2020 project NANoREG II that focuses on Safe by design and that will start in the 2nd or 3rd quarter of 2015.

The coordinated and integrated approach in developing the Framework and the NANoREG Toolbox is one of the main elements of the H2020 funded Coordination and Support Action (CSA) “ProSafe” that recently had its Kick-Off meeting in Aix-en-Provence, France. Just like NANoREG this CSA is coordinated by the Dutch Ministry of Infrastructure and the Environment and as such executed by me. Other elements of this CSA are – among others – the expansions of the involvement of EU and non-EU countries in the NANoREG project in order to broaden the platform of support for the NANoREG results world-wide (“NANoREG+”), the exploitation of synergies between the NANoREG project and other “nanosafety” projects and data management.

The outcome of the CSA will be a White Paper that can be used by policy makers, regulators and industry to establish methods for measuring and assessing the EHS aspects of nanomaterials and that will give guidance to industry how to implement “safe by design“. A forerunner of the White Paper will be subject of a three days scientific conference to be held at the end of 2016. It will include the results of the NANoREG project, the results of the evaluation of EHS data available at the OECD and results from other sources. After consulting Risk assessors and policymakers, the White Paper will be published in the first quarter of 2017.

This project has reached out beyond Europe for partners (from the editorial for the 3rd NANoREG newsletter),

It is quite a challenge we face. Given the expertise and scientific authority of our partners, including the Czech-,Brazilian- and South Korean parties that recently joined the NANoREG project, I am confident however that we will succeed in reaching our goal: creating a solid basis for a balanced combination of nanosafety and innovation that will be beneficial to society.

I hope NANoREG is successful with its goal of “creating a solid basis for a balanced combination of nanosafety and innovation that will be beneficial to society.”

There is a general perception that nanotechnologies will have a significant impact on developing ‘green’ and ‘clean’ technologies with considerable environmental benefits. The associated concept of green nanotechnology aims to exploit nanotech-enabled innovations in materials science and engineering to generate products and processes that are energy efficient as well as economically and environmentally sustainable. These applications are expected to impact a large range of economic sectors, such as energy production and storage, clean up-technologies, as well as construction and related infrastructure industries.

A recent review article in Environmental Health (“Opportunities and challenges of nanotechnology in the green economy”) examines opportunities and practical challenges that nanotechnology applications pose in addressing the guiding principles for a green economy.

Here’s a link to and citation for the review article cited by Berger. It is more focused on occupational health and safety then the title suggests but not surprising when you realize all of the authors are employed by the US National Institute of Occupational Safety and Health (NIOSH),,

Here’s the background to the work (from the article; Note: Links have been removed),

The “green economy” concept has been driven into the mainstream of policy debate by global economic crisis, expected increase in global demand for energy by more than one third between 2010 to 2035, rising commodity prices as well as the urgent need for addressing global challenges in domains such as energy, environment and health [1-3].

The term “green economy”, chiefly relating to the principles of sustainable development, was first coined in a pioneering 1989 report for the Government of the United Kingdom by a group of leading environmental economists [1]. The most widely used and reliable definition of “green economy” comes from the United Nations Environment Programme which states that “a green economy is one that results in improved human well-being and social equity, while significantly reducing environmental risks and ecological scarcities. It is low carbon, resource efficient, and socially inclusive” [4].

…

The green economy concept can indeed play a very useful role in changing the way that society manages the interaction of the environmental and economic domains. In this context, nanotechnology, which is the manipulation of matter in the dimension of 1 to 100 nm, offers the opportunity to produce new structures, materials and devices with unique physico-chemical properties (i.e. small size, large surface area to mass ratio) to be employed in energy efficient as well as economically and environmentally sustainable green innovations [8-12].

Although expected to exert a great impact on a large range of industrial and economic sectors, the sustainability of green nano-solutions is currently not completely clear, and it should be carefully faced. In fact, the benefits of incorporating nanomaterials (NMs) in processes and products that contribute to outcomes of sustainability, might bring with them environmental, health and safety risks, ethical and social issues, market and consumer acceptance uncertainty as well as a strong competition with traditional technologies [13].

The present review examines opportunities and practical challenges that nano-applications pose in addressing the guiding principles for a green economy. Examples are provided of the potential for nano-applications to address social and environmental challenges, particularly in energy production and storage thus reducing pressure on raw materials, clean-up technologies as well as in fostering sustainable manufactured products. Moreover, the review aims to critically assess the impact that green nanotechnology may have on the health and safety of workers involved in this innovative sector and proposes action strategies for the management of emerging occupational risks.

The potential nanotechnology impact on green innovations

Green nanotechnology is expected to play a fundamental role in bringing a key functionality across the whole value chain of a product, both through the beneficial properties of NMs included as a small percentage in a final device, as well as through nano-enabled processes and applications without final products containing any NMs [13,14]. However, most of the potential green nano-solutions are still in the lab/start-up phase and very few products have reached the market to date. Further studies are necessary to assess the applicability, efficiency and sustainability of nanotechnologies under more realistic conditions, as well as to validate NM enabled systems in comparison to existing technologies. The following paragraphs will describe the potential fields of application for green nanotechnology innovations.

Intriguingly, there’s no mention (that I could find) of soil remediation (clean-up) although there is reference to water remediation. As for occupational health and safety and nanotechnology, the authors have this to say (Note: Links have been removed),

In this context according to the proposed principles for green economy, it is important that society, scientific community and industry take advantage of opportunities of nanotechnology while overcoming its practical challenges. However, not all revolutionary changes are sustainable per se and a cautious assessment of the benefits addressing economic, social and environmental implications, as well as the occupational health and safety impact is essential [95,96]. This latter aspect, in particular, should be carefully addressed, in consideration of the expected widespread use of nanotechnology and the consequent increasing likelihood of NM exposure in both living and occupational environments. Moreover, difficulties in nano-manufacturing and handling; uncertainty concerning stability of nano-innovations under aggressive or long-term operation (i.e. in the case of supercapacitors with nano-structured electrode materials or nano-enabled construction products); the lack of information regarding the release and fate of NMs in the environment (i.e. NMs released from water and wastewater treatment devices) as well as the limited knowledge concerning the NM toxicological profile, even further support the need for a careful consideration of the health and safety risks derived from NM exposure.Importantly, as shown in Figure 1, a number of potentially hazardous exposure conditions can be expected for workers involved in nanotechnology activities. In fact, NMs may have significant, still unknown, hazards that can pose risks for a wide range of workers: researchers, laboratory technicians, cleaners, production workers, transportation, storage and retail workers, employees in disposal and waste facilities and potentially, emergency responders who deal with spills and disasters of NMs who may be differently exposed to these potential, innovative xenobiotics.

The review article is quite interesting, albeit its precaution-heavy approach, but if you don’t have time, Berger summarizes the article. He also provides links to related articles he has written on the subjects of energy storage, evaluating ‘green’ nanotechnology in a full life cycle assessment, and more.

Belgium will be the second country in the European Union (France being the first) to enact a mandatory register for nanomaterials. A Sept. 3, 2014 Nanowerk Spotlight article by Anthony Bochon (Attorney at the Brussels Bar, Associate at Squire Patton Boggs (UK) LLP Brussels office, Associate lecturer at the Université libre de Bruxelles and fellow at Stanford Law School) provides details (Note: A link has been removed),

On 7th February 2014, the Belgian federal government issued a press release declaring that the draft Royal Decree creating a Belgian register for nanomaterials has been approved. Although its not been formally enacted yet, its content has been disclosed to the European Commission on 19th February 2014. The Royal Decree would enter into force on 1st January 2016 for substances manufactured at the nanoscale and on 1st January 2017 for preparations containing a substance or substances manufactured at the nanoscale. [emphases mine]

…

The scope of the Belgian nano register is twofold with the scopes by product and by activity that delineate the cases when a declaration or notification would be filled with the Ministry of Health.

Scope by product

The registration requirements will apply to products which are or which include substances manufactured at nanoscale. The central issue with the registration requirements was and remains the definition of the so-called “substance manufactured at nanoscale”. In absence of any common compulsory definition in EU law, the Belgian government has decided to adopt the definition proposed by the European Commission in its recommendation of 18th October 2011. The Royal Decree defines the “substance manufactured at nanoscale” as “a substance containing unbound particles or particles in the form of an aggregate or agglomerate, of which a minimum proportion of at least fifty per cent of the size distribution, by number, have one or more external dimensions within the range of one nanometre and one hundred nanometres, excluding chemically unmodified natural substances, accidentally produced substances and substances whose fraction between one nanometre and one hundred nanometres is a by-product of human activity. Fullerenes, graphene flakes and single-wall carbon nanotubes with one or more external dimensions below one nanometre shall be treated as substances manufactured at the nanoscale.”
Companies will have to determine with their counsel if their products fall within the product scope of application of the Belgian nano register. The choice of such definition has already faced some serious criticism during the preparatory phase of the Royal Decree. It is unsure whether this definition would survive a legality test or whether the federal government will not broaden the product scope of application. Unlike the Commission recommendation of 18th October 2011, the Belgian definition of nanomaterials does not encompass materials with a specific surface area by volume of the material greater than 60 m2/cm3 but which does not meet the 50% size distribution requirement.

A certain number of products will be excluded from the notification or declaration requirements set out in the Royal Decree:

Cosmetics products which have been notified in accordance with Regulation 1223/2009 on cosmetic products;

Biocides falling within the scope of Regulation 528/2012 (the Biocides Regulation) and which have been registered or authorized in accordance with the Royal Decree of 22 May 2003 concerning the placing on the market and use of biocides;

Medicines for human and veterinary use falling within the scope of Regulation 726/2004 or the Royal Decree of 14 December 2006 on medicinal products for human and veterinary use

Foodstuffs and materials and objects intended to come into contact with foodstuffs referred to in Article 1, 1° and 2°, b) of the Law of 24 January 1977 on the protection of consumer health in regard to foodstuffs and other products

Animal feed, as defined in Article 3 of Regulation 178/2002

Medicines and medicated animal feed falling within the scope of the Law of 21 June 1983 on medicated animal feed;

Processing aids and other products which may be used in processing organically produced agricultural ingredients, mentioned in Part B of Annex VIII to Commission Regulation (EC) No 889/2008

Pigments, defined as substances which are insoluble in typical suspension media, used for their optical properties in a preparation or article.

It is important to point out that complex articles containing carbon black, amorphous synthetic silica or precipitated calcium carbonate, used as fillers, are excluded from the notification requirements laid down by the Royal Decree.

It’s fascinating to note the materials being excluded from this registry. I expect most of those materials/products are already covered under other regulations or decrees as are, for example, cosmetics, since the EU requires cosmetics companies to label (and, presumably, to register) products containing nanomaterials.

There’s a lot more to the article than the bits I have excerpted here so I encourage anyone interested in regulatory matters to read the piece in its entirety.

The author, Anthony Bochon, was last mentioned here in an Aug. 15, 2014 posting, about his forthcoming 2015 book, Nanotechnology Law & Guidelines: A Practical Guide for the Nanotechnology Industries in Europe.

The first part of this food and nano ‘debate’ started off with the May 22, 2014 news item on Nanowerk announcing the Friends of the Earth (FOE) report ‘Way too little: Our Government’s failure to regulate nanomaterials in food and agriculture‘. Adding energy to FOE’s volley was a Mother Jones article written by Tom Philpott which had Dr. Andrew Maynard (Director of the University of Michigan’s Risk Science Center) replying decisively in an article published both on Nanowerk and on the Conversation.

The second part of this series focused largely on a couple of research efforts (a June 11, 2014 news item on Nanowerk highlights a Franco-German research project, SolNanoTox) and in the US (a June 19, 2014 news item on Azonano about research from the University of Arizona focusing on nanoscale additives for dietary supplement drinks) and noted another activist group’s (As You Sow) initiative with Dunkin’ Donuts (a July 11, 2014 article by Sarah Shemkus in a sponsored section in the UK’s Guardian newspaper0).

This final part in the series highlights the US Food and Drug Administration’s (FDA) final guidance document on nanomaterials and food issued some five weeks after the FOE’s report and an essay by a Canadian academic on the topic of nano and food.

The Food and Drug Administration June 24 [2014] announced new guidance to provide greater regulatory clarity for industry on the use of nanotechnology in FDA-regulated products, including drugs, devices, cosmetics and food.

…

In this final guidance, the agency said that nanotechnology “can be used in a broad array of FDA-regulated products, including medical products (e.g., to increase bioavailability of a drug), foods (e.g., to improve food packaging) and cosmetics (e.g., to affect the look and feel of cosmetics).”

…

Also on the agency website, the FDA said it “does not make a categorical judgment that nanotechnology is inherently safe or harmful. We intend our regulatory approach to be adaptive and flexible and to take into consideration the specific characteristics and the effects of nanomaterials in the particular biological context of each product and its intended use.”

…

This July 18, 2014 posting by Jeannie Perron, Miriam Guggenheimm and Allan J. Topol of Covington & Burling LLP on the National Law Review blog provides a better summary and additional insight,

On June 24, 2014, the Food and Drug Administration (FDA) released three final guidance documents addressing the agency’s general approach to nanotechnology and its use by the food and cosmetics industries, as well as a draft guidance on the use of nanomaterials in food for animals.

These guidance documents reflect FDA’s understanding of nanomaterials as an emerging technology of major importance with the potential to be used in novel ways across the entire spectrum of FDA- regulated products.

The documents suggest that FDA plans to approach nanotechnology-related issues cautiously, through an evolving regulatory structure that adapts to manufacturers’ changing uses of this technology. FDA has not established regulatory definitions of “nanotechnology,” “nanomaterial,” “nanoscale,” or other related terms. …

The notion of an “evolving regulatory structure” is very appealing in situations with emerging technologies with high levels of uncertainty. It’s surprising that more of the activist groups don’t see an opportunity with this approach. An organization that hasn’t devised a rigid regulatory structure has no investment in defending it. Activist groups can make the same arguments, albeit from a different perspective, about an emerging technology as the companies do and, theoretically, the FDA has become a neutral party with the power to require a company to prove its products’ safety.

You can find the FDA final guidance and other relevant documents here.

Finally, Sylvain Charlebois, associate dean at the College of Business and Economics at the University of Guelph, offers a rather provocative (and not from the perspective you might expect given his credentials) opinion on the topic of ‘nano and food’ in a July 18, 2014 article for TheRecord.com,

Nanotechnology and nanoparticles have been around for quite some time. In fact, consumers have been eating nanoparticles for years without being aware they are in their food.

Some varieties of Dentyne gum and Jell-O, M&M’s, Betty Crocker whipped cream frosting, Kool-Aid, Pop-Tarts, you name it, contain them. Even food packaging, such as plastic containers and beer bottles, have nanoparticles.

While consumers and interest groups alike are registering their concerns about genetically modified organisms, the growing role of nanotechnology in food and agriculture is impressive. When considering the socio-economic and ethical implications of nanotechnology, comparisons to the genetic modification debate are unavoidable.

…

The big picture is this. For years, capitalism has demonstrated its ability to create wealth while relying on consumers’ willingness to intrinsically trust what is being offered to them. With trans fats, genetically modified organisms and now nanoparticles, our food industry is literally playing with fire. [emphasis mine]

Most consumers may not have the knowledge to fully comprehend the essence of what nanotechnology is or what it can do. However, in an era where data access in almost constant real-time is king, the industry should at least give public education a shot.

In the end and despite their tactics, the activist groups do have a point. The food and agricultural industries need to be more frank about what they’re doing with our food. As Charlebois notes, they might want to invest in some public education, perhaps taking a leaf out of the Irish Food Board’s book and presenting the public with information both flattering and nonflattering about their efforts with our food.

ETA Sept. 1, 2014: Even more coincidentally, Michael Berger has written a 2nd Nanowerk Spotlight (dated Aug. 25, 2014) on the food and nano topic titled, ‘Nanotechnology in Agriculture’ based on the European Union’s Joint Research Centre’s ‘Workshop on Nanotechnology for the agricultural sector: from research to the field”, held on November 21-22 2013′.

The first part of this roughly six week food and nano ‘debate’ started off with the May 22, 2014 news item on Nanowerk announcing the Friends of the Earth (FOE) report ‘Way too little: Our Government’s failure to regulate nanomaterials in food and agriculture‘. Adding energy to FOE’s volley was a Mother Jones article written by Tom Philpott which had Dr. Andrew Maynard (Director of the University of Michigan’s Risk Science Center) replying decisively in an article published both on Nanowerk and on the Conversation.

Coincidentally or not, there were a couple of news items about ‘nano and food’ research efforts during the ‘debate’. A June 11, 2014 news item on Nanowerk highlights a Franco-German research project into the effects that nanomaterials have on the liver and the intestines while noting the scope of the task researchers face,

What mode of action do nanomaterials ingested via food have in liver and intestine? Which factors determine their toxicity? Due to the large number of different nanomaterials, it is hardly possible to test every one for its toxic properties. [emphasis mine] For this reason, specific properties for the classification of nanomaterials are to be examined within the scope of the Franco-German research project “SolNanoTox”, which began on 1 March 2014. The [German] Federal Institute for Risk Assessment (BfR) requires data on bioavailability for its assessment work, in particular on whether the solubility of nanomaterials has an influence on uptake and accumulation in certain organs, such as liver and intestine. “We want to find out in our tests whether the criterion ‘soluble or insoluble’ is a determining factor for uptake and toxicity of nanomaterials,” says BfR President Professor Dr. Andreas Hensel.

A risk assessment of nanomaterials is hardly possible at the moment and involves a very high degree of uncertainty, as important toxicological data on their behaviour in tissue and cells are still missing. [emphasis mine] The German-French SolNanoTox research project examines which role the solubility of nanomaterials plays with regard to their accumulation and potential toxic properties. The project is to run for three and a half years during which the BfR will work closely with its French sister organisation ANSES. Other partners are the Institut des Sciences Chimiques de Rennes and Universität Leipzig. The German Research Foundation and French Agence Nationale de la Recherche (ANR) are funding the project.

The tasks of the BfR include in vitro tests (e.g. the investigation of the influence of the human gastrointestinal system) and analysis of biological samples with regard to the possible accumulation of nanomaterials. In addition to this, the BfR uses modern methods of mass spectrometry imaging to find out whether nanoparticles alter the structure of biomolecules, e.g. the structure of the lipids of the cellular membrane. So far, these important tests, which are necessary for assessing possible changes in DNA or cellular structures caused by nanomaterials in food, have not been conducted.

Metallic nanoparticles are to be studied (from the press release),

In the project, two fundamentally different types of nanoparticles are examined as representatives for others of their type: titanium dioxide as representative of water insoluble nanoparticles and aluminium as an example of nanomaterials which show a certain degree of water solubility after oxidation. [emphases mine] It is examined whether the degree of solubility influences the distribution of the nanomaterials in the body and whether soluble materials may possibly accumulate more in other organs than insoluble ones. The object is to establish whether there is a direct toxic effect of insoluble nanomaterials in general after oral uptake due to their small size.

Different innovative analytical methods are combined in the project with the aim to elucidate the behaviour of nanomaterials in tissue and their uptake into the cell. The main focus is on effects which can trigger genotoxic damage and inflammation. At first, the effects of both materials are examined in human cultures of intestinal and liver cells in an artificial environment (in vitro). In the following, it has to be verified by animal experimentation whether the observed effects can also occur in humans. This modus operandi allows to draw conclusions on effects and mode of action of orally ingested nanomaterials with different properties. The goal is to group nanomaterials on the basis of specific properties and to allocate the corresponding toxicological properties to these groups. Motivation for the project is the enormous number of nanomaterials with large differences in physicochemical properties. Toxicological tests cannot be conducted for all materials.

In the meantime, a June 19, 2014 news item on Azonano (also on EurekAlert but dated June 18, 2014) features some research into metallic nanoparticles in dietary supplement drinks,

Robert Reed [University of Arizona] and colleagues note that food and drink manufacturers use nanoparticles in and on their products for many reasons. In packaging, they can provide strength, control how much air gets in and out, and keep unwanted microbes at bay. As additives to food and drinks, they can prevent caking, deliver nutrients and prevent bacterial growth. But as nanoparticles increase in use, so do concerns over their health and environmental effects. Consumers might absorb some of these materials through their skin, and inhale and ingest them. What doesn’t get digested is passed in urine and feces to the sewage system. A handful of initial studies on nanomaterials suggest that they could be harmful, but Reed’s team wanted to take a closer look.

They tested the effects of eight commercial drinks containing nano-size metal or metal-like particles on human intestinal cells in the lab. The drinks changed the normal organization and decreased the number of microvilli, finger-like projections on the cells that help digest food. In humans, if such an effect occurs as the drinks pass through the gastrointestinal tract, these materials could lead to poor digestion or diarrhea, they say. The researchers’ analysis of sewage waste containing these particles suggests that much of the nanomaterials from these products are likely making their way back into surface water, where they could potentially cause health problems for aquatic life.

This piece is interesting for two reasons. First, the researchers don’t claim that metallic nanoparticles cause digestion or diarrhea due to any action in the gastrointestinal tract. They studied the impact that metallic nanoparticles in supplementary drinks had on cells (in vitro testing) from the gastrointestinal tract. Based on what they observed in the laboratory, “… these materials could lead to poor digestion or diarrhea… .” The researchers also suggest a problem could occur as these materials enter surface water in increasing quantities.

With Paul Westerhoff as one of the authors and the reference to metallic nanoparticles entering water supplies, I’m guessing that this research is associated with the LCnano (lifecycle nano) project headquartered at Arizona State university (April 8, 2014 posting).

Getting back to the Franco-German SolNanoTox project, scientists do not know what happens when the cells in your intestines, liver, etc. encounter metallic or other nanoparticles, some of which may be naturally occurring. It should also be noted that we have likely been ingesting metallic nanoparticles for quite some time. After all, anyone who has used silver cutlery has ingested some silver nanoparticles.

There are many, many questions to be asked and answered with regard to nanomaterials in our foods. Here are a few of mine:

How many metallic and other nanoparticles did we ingest before the advent of ‘nanomaterials in food’?

What is the biopersistence of naturally occurring and engineered metallic and other nanoparticles in the body?

What happens as the metallic and other engineered nanoparticles are added to food and drink and eventually enter our water, air, and soil?

Returning to the ‘debate’, a July 11, 2014 article by Sarah Shemkus for a sponsored section in the UK’s Guardian newspaper highlights an initiative taken by an environmental organization, As You Sow, concerning titanium dioxide in Dunkin’ Donuts’ products (Note: A link has been removed),

The activists at environmental nonprofit As You Sow want you to take another look at your breakfast doughnut. The organization recently filed a shareholder resolution asking Dunkin’ Brands, the parent company of Dunkin’ Donuts, to identify products that may contain nanomaterials and to prepare a report assessing the risks of using these substances in foods.

Their resolution received a fair amount of support: at the company’s annual general meeting in May, 18.7% of shareholders, representing $547m in investment, voted for it. Danielle Fugere, As You Sow’s president, claims that it was the first such resolution to ever receive a vote. Though it did not pass, she says that she is encouraged by the support it received.

“That’s a substantial number of votes in favor, especially for a first-time resolution,” she says.

The measure was driven by recent testing sponsored by As You Sow, which found nanoparticles of titanium dioxide in the powdered sugar that coats some of the donut chain’s products. [emphasis mine] An additive widely used to boost whiteness in products from toothpaste to plastic, microscopic titanium dioxide has not been conclusively proven unsafe for human consumption. Then again, As You Sow contends, there also isn’t proof that it is harmless.

“Until a company can demonstrate the use of nanomaterials is safe, we’re asking companies either to not use them or to provide labels,” says Fugere. “It would make more sense to understand these materials before putting them in our food.”

As You Sow is currently having 16 more foods tested. The result should be available later this summer, Fugere says.

I wonder if As You Sow will address the question of whether the nanoscale titanium dioxide they find indicates that nanoscale particles are being deliberately added or whether the particles are the inadvertent consequence of the production process. That said, I find it hard to believe no one in the food industry is using engineered nanoscale additives as they claim (the other strategy is to offer a nonanswer) in Shemkus’ article (Note: Links have been removed).,

In a statement, Dunkin’ Donuts argues that the titanium dioxide identified by As You Sow does not qualify as a nanomaterial according to European Union rules or draft US Food and Drug Administration regulations. The company also points out that there is no agreed-upon standard method for identifying nanoparticles in food.

…

In 2008, As You Sow filed nanomaterial labeling resolutions with McDonald’s and Kraft Foods. In response, McDonald’s released a statement declaring that it does not support the use of nanomaterials in its food, packaging or toys. Kraft responded that it would make sure to address health and safety concerns before ever using nanomaterials in its products.

While Shemkus’ article appears in the Guardian’s Food Hub which is sponsored by the Irish Food Board, this article manages to avoid the pitfalls found in Philpott’s nonsponsored article.

It seems the food and nano debate of Spring/Summer 2014 has died down, for a while at least. The first volley (from my perspective) was the May 2014 release of ‘Way too little: Our Government’s failure to regulate nanomaterials in food and agriculture’ by the Friends of the Earth (FOE) Australia. Here’s how the report is described in a May 22, 2014 news item on Nanowerk,

Friends of the Earth’s new report, Way too little (pdf), looks at the now widespread presence of nanomaterials in our food chain and how little Food Standards Australia New Zealand (FSANZ) is doing to ensure our safety.

This report will examine the changes since our 2008 report including the development of new food, food contact and agricultural products. It will review the current literature relating to the potential environmental, health and safety impacts associated with nanotechnology and summarise the Australian regulatory responses to date.

This updated report uncovers the:

•accelerating rate of commercialisation and rapidly increasing number of commercial products containing nanomaterials in the food and agricultural sectors;

•lack of information regarding which nanomaterials have been released and the likely exposure of humans and natural systems to these materials;

•lack of basic steps to allow us to track nanomaterials that have been released, such as
labelling and a register of products containing nanomaterials;

•growing gap between the pace of commercialisation and environmental, health and safety assessments;

•increasingly large body of peer reviewed evidence that certain nanomaterials may cause harm to human health or the environment;

•failure of regulators to respond to the growingevidence of risks;

•lack of basic knowledge that is critical in order to fully analyse the particular environmental, health and safety issues associated with nanotechnology.

Six years ago, inaction was based on a perceived lack of data. Inaction is still the norm but that is no longer an excuse our Government can use. Scientists and scientific bodies such as the US National Research Council have given us more than enough evidence to justify a pro-active regulatory regime and a properly funded R&D program that will effectively target those areas of greatest environmental and health concern.

Unfortunately, our Federal Government seems unwilling to provide the levels of funding required for such work or to adopt appropriate regulation. The notion of precaution has been replaced with an attitude that it is the obligation of industry to determine whether their products are safe and regulators will only act when harm is shown. While France, Belgium and Denmark are implementing a mandatory register for nanomaterials and the EU’s is in the process of implementing a nano food labelling regime, Australian consumers remain in the dark.

This needs to change.

One of the issues with increased regulation and labeling is whether the benefits outweigh disadvantages such as the increased difficulty of getting needed foodstuffs to the marketplace and, of course, cost.

Tom Philpott in a May 28, 2014 article for Mother Jones magazine titled ‘Big Dairy Is Putting Microscopic Pieces of Metal in Your Food’ is a strong proponent for FOE’s position, albeit his geographic focus is the US and he seems most concerned with metallic nanoparticles (Note: Links have been removed),

Examples include Silk Original Soy Milk, Rice Dream Rice Drink, Hershey’s Bliss Dark Chocolate, and Kraft’s iconic American Cheese Singles, all of which now contain nano-size titanium dioxide*. As recently as 2008, only eight US food products were known to contain nanoparticles, according to a recent analysis [May 2014 report] from Friends of the Earth—a more than tenfold increase in just six years.

Philpott goes on to mention the US Food and Drug Administration’s (FDA) 2012 draft guidance on nanomaterials and food,

Back in 2012, the FDA released a draft, pending public comment, of a proposed new framework for bringing nano materials into food. The document reveals plenty of reason for concern. For example: “so-called nano-engineered food substances can have significantly altered bioavailability and may, therefore, raise new safety issues that have not been seen in their traditionally manufactured counterparts.” The report went on to note that “particle size, surface area, aggregation/agglomeration, or shape may impact absorption, distribution, metabolism and excretion (ADME) and potentially the safety of the nano-engineered food substance.”

What FDA is saying here is obvious: If nanoparticles didn’t behave differently, the industry wouldn’t be using them in the first place.

So what’s the remedy? Rather than require rigorous safety studies before companies can lace food with nanoparticles, the FDA’s policy draft proposes “nonbinding recommendations” for such research. Even that rather porous safety net doesn’t yet exist—the agency still hasn’t implemented the draft proposal it released more than two years ago.[emphasis mine]

June 27, 2014, the FDA issued a final ‘food and nanotechnology’ guidance document (more on that later).

Recently the American publication Mother Jones published an article on the dangers of food laced with tiny metal oxide particles. The article, however, is laced with errors and misinformation.

The source material for the article came from a report by the environmental organisation Friends of the Earth, an online database of nanotechnology-based consumer products and a peer-reviewed paper published in 2012. However, the analysis of the information is flawed.

..

Bad journalism

The inventory Philpott cites is the Project on Emerging Nanotechnologies Consumer Products Inventory, which I helped establish in 2006 as a way better understand the increasing number of consumer products that were using engineered nanomaterials. It provides a useful but only qualitative sense of what was being used where, and relies on intermittent web searches and other sources of intelligence. The inventory was never meant to be comprehensive or authoritative.

Briefly, Andrew’s argument is that the FOE report (Way too little) which claims a tenfold increase since 2008 of food products with added nano titanium dioxide (and which Philpotts uses to build his case) is erroneous. In 2006, the inventory was voluntary and there was no oversight. At that time, eight food products had been added to the list. In 2013, the inventory was revived (Oct. 28, 2013 posting) and new information added from a 2012 academic paper. The products from the 2012 paper may have predated the 2006 inventory products, or not. There is no way to tell. Andrew notes this in his measured way,

As someone who works on the risks and benefits of nanotechnology, I can see how errors in translation crept into this story. The 2012 paper was addressing a legitimate concern that little is know about how much titanium dioxide is in the processed food chain. The Consumer Products Inventory provides important and unique insights into nanoparticles being used in products. Friends of the Earth have every right to ask what is known about the potential risks in what we’re eating. And reporters like Philpott have a professional obligation to highlight issues of concern and interest to their readers.

The problem with exaggerated and inflated claims is that FOE proves itself to be an unreliable source and Philpott’s failure to investigate adequately puts his own credibility into question. How can you trust either FOE’s materials or Philpott’s articles? The easiest way to begin rebuilding credibility is to admit one’s mistakes. To date, I have not seen any such attempts from FOE or Philpott.

Coming next: a research initiative into the health effects of nano and food and a research paper on nano in commercial drinks both of which help illustrate why there are concerns and why there is a reluctance to move too quickly.